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Deep Brain Stimulation of the Sub-Thalamic Nucleus to Treat Severe and Treatment-resistant Cocaine Addiction. (STUC)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02892851
First received: August 18, 2016
Last updated: September 1, 2016
Last verified: August 2016
  Purpose

Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and social complications. Cocaine is the second most consumed illicit drug in France. Its prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise. Craving, the compulsive need to consume, is a key feature of cocaine addiction. It is also predictive of treatment efficacy. However, there is no validated treatment for severe cocaine dependence yet. Response to current psychological and medical treatment is poor, with 73% relapse after 3 months. Patients with severe cocaine addiction are thus in a therapeutic deadlock.

To address these unmet medical needs, the investigators designed a pilot study (n=2) to evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric complication. Indeed, compulsivity is a critical component of craving, and severe treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of STN-DBS in rats addicted to cocaine. Together, these two lines of research suggest a therapeutic effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism on craving.


Condition Intervention
Cocaine Addiction Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Deep Brain Stimulation of the Sub-thalamic Nucleus to Treat Treatment-resistant Cocaine Addiction With Severe Somatic or Psychiatric Complications

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score [ Time Frame: at month 6 ]

Secondary Outcome Measures:
  • Psychiatric assessment by standardized interview [ Time Frame: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) ]
  • Cocaine Craving Questionnaire (CCQ) craving score [ Time Frame: Month -2, Month 2 (1day), Month 2 (2nd day), Month 2 (3rd day), Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month 10 (+1,5) ]
  • Self assessed addiction criteria [ Time Frame: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) ]
  • Urine screening assay for cocaine use / Urine Drug Screening [ Time Frame: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) ]
  • Capillary screening assay for cocaine use [ Time Frame: Month -2, Month 4,5 and Month 10 (+1,5) ]
  • Evolution of Global Assessment of Functioning scale (GAF) [ Time Frame: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) ]

Estimated Enrollment: 2
Study Start Date: March 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep brain stimulation (DBS)
Deep brain stimulation of the subthalamic nuclei (STN-DBS)
Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS)

3 phases :

  • Parameter setting
  • Cross-over double-bind (ON/OFF)
  • Open Phase (ON)
Other Name: Activa PC Medtronic (7428) stimulator

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe and resistant Cocaine Dependence for 5 years defined as:

    • cocaine dependence (DSM IV),
    • preferential use of cocaine in base form (crack or free-base) through smoke,
    • non response to at least two well-conducted treatment with at least a stay in aftercare,
    • severe physical complications (defined as a history of myocardial infarction, stroke).
  • psychotic syndromes induced recurrent, severe lung disease "crack-lungs") occurred due to crack consumption and whose association with the crack use is known to the patient
  • age between 30 and 55 years
  • patient affiliated to a social security scheme
  • patient signed an informed consent after receiving written information on the proposed procedure

Exclusion Criteria:

  • a current opioid dependence will not be a criterion of non inclusion if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least six months.
  • patient trust
  • pregnant, nursing or of childbearing potential without effective contraception
  • current use of the intravenous route for the administration of the drugs is the risk of infection
  • VIH infection or VHC unstabilized,
  • cardiovascular and / or brain state is not compatible with the surgery,
  • other disorder on Axis I not linked to cocaine use except:

    • current or past dependence to nicotine,
    • abuse or dependence on other psychoactive substances over a lifetime in remission for more than 6 months,
    • current opioid dependence: if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least 6 months,
    • when other psychiatric disorders induced by substances.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02892851

Contacts
Contact: Luc MALLET (0)1 49 81 30 52 ext +33 luc.mallet@inserm.fr
Contact: Florence VORSPAN (0) 1 40 05 44 17 ext +33 florence.vorspan@aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Philippe DOMENECH    (0) 1 49 81 22 03 ext +33    philippe.domenech@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02892851     History of Changes
Other Study ID Numbers: P111014
Study First Received: August 18, 2016
Last Updated: September 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
STN-DBS
Craving
Cocaine addiction

Additional relevant MeSH terms:
Mental Disorders
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 19, 2017